To compare the clinical outcomes of aflibercept used with a fixed schedule with a pro-re-nata (PRN) retreatment regimen in patients affected by neovascular age-related macular degeneration.
This is a prospective multicenter, noninferiority, propensity score–matched study evaluating the 12-month outcomes of aflibercept given either according to labeling or following a PRN regimen. Patients included in the latter group received one initial injection, followed by monthly visits and as-needed retreatment.
One-to-one matching resulted in fixed and PRN arms containing 92 eyes each. Visual acuity improved from baseline to 12 months in both the study groups. At Month 4, the fixed regimen was equivalent to the PRN regimen (mean difference: 1.75 Early Treatment Diabetic Retinopathy Study letters, 95% confidence interval: −1.42 to +4.92). The pro-re-nata regimen failed to show noninferiority compared with the fixed regimen at both Month 8 (mean difference: 3.43 Early Treatment Diabetic Retinopathy Study letters, 95% confidence interval: +0.25 to +6.22) and Month 12 (mean difference: 4.83 Early Treatment Diabetic Retinopathy Study letters, 95% confidence interval: +1.37 to +8.29). All patients in the fixed group received seven injections. Patients included in the PRN arm received a mean of 5.5 ± 1.6 treatments.
Aflibercept given with a fixed treatment regimen produces better visual acuity outcomes than an individualized regimen.
The treatment of wet age-related macular degeneration with intravitreal aflibercept produces better functional results when the drug is administered using a fixed and proactive schedule than when using an individualized and reactive dosing regimen.
*Department of Medicine—Ophthalmology, University of Udine, Udine, Italy;
†European Institute of Ocular Microsurgery—IEMO, Udine, Italy; and
‡Department of Ophthalmology, University of Rome Tor Vergata, Rome, Italy.
Reprint requests: Paolo Lanzetta, MD, Department of Medicine—Ophthalmology, University of Udine, Piazzale Santa Maria della Misericordia, 33100 Udine, Italy; e-mail: firstname.lastname@example.org
The study was conducted in accordance with the Declaration of Helsinki. Two authors serve as consultants for the following companies: F. Ricci: Alcon, C; Allergan, C; Bayer, C; Novartis Pharma, C; Regeneron, C; and Roche, C; P. Lanzetta: Alcon, C; Alimera, C; Allergan, C; Bausch & Lomb, C; Bayer, C; Boehringer, C; CenterVue, C; Genentech, C; Lupin, C; Lutronic, C; Novartis Pharma AG, C; Roche, C; Teva, C; and Topcon, C.